Bioprocess Specialist

1 month ago

Toronto, Ontario, Canada Hyde Engineering + Consulting Full time
Job Title: Bioprocess Specialist

Hyde Engineering + Consulting is seeking a highly skilled Bioprocess Specialist to join our team. As a Bioprocess Specialist, you will play a critical role in supporting the design phase of new production facilities, including conceptual, basis of design, and detailed design. You will work closely with our team to ensure that all equipment, processes, and utilities meet the highest standards of quality and safety.

Key Responsibilities:
  • Support the design and specification of cGMP equipment, processes, and utilities for biopharma projects.
  • Create and review project documentation, including URS, FRS, Technical Specifications, and Functional Specifications.
  • Develop and review process models and sizing calculations for process equipment, control valves, and other critical systems.
  • Manage and populate equipment/line/valve/instrument lists and equipment data sheets.
  • Liaise with client end-user groups to ensure correct specification of equipment and utilities.
  • Develop Technical Specifications and Functional Specifications for automated and manual equipment.
  • Specify requirements for tanks, valves, pumps, fermenters, centrifuges, UF/DF systems, chromatography columns, and other critical equipment.
  • Sizing and specification of utility systems, including clean and plant steam, compressed air, and waste systems.
  • Provide engineering expertise and drive technical decisions as an active member of our team.
Requirements:
  • BS degree or higher in chemical or mechanical engineering.
  • 5-8 years of experience in the Biopharmaceutical industry, preferably in a consulting capacity.
  • Demonstrated engineering project management experience, ideally in a construction environment.
  • Familiarity with process design and operations, including block flow diagrams and process flow diagrams.
  • Experience with downstream processing, including TFF, microfiltration, ultrafiltration, centrifuge, depth filters, harvest, and purification.
  • Experience with Fill/Finish and startup, walkdowns, as-built P&IDs, FAT, SAT, and commissioning.
  • Excellent knowledge of ASME BPE, ISPE, and FDA cGMP requirements.
  • Strong verbal and written communication skills.
  • Ability to work independently and within project teams.
  • Industry experience related to cGMP drug manufacturing, validation, and chemical process design.
  • Strong computer knowledge, including Microsoft Office products.

At Hyde Engineering + Consulting, we are committed to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. If you are passionate about making a difference in the world, consider joining our team of dedicated professionals.

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